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Phase III, multicentre, randomized, double-blind, parallel group, long-term study investigating the efficacy and safety of the 5mg and 10mg doses of PGL4001 for the treatment of uterine myoma.
The target population is composed of pre-menopausal women with symptomatic uterine myoma(s) characterised by heavy bleeding.The main objective of this study is to assess the sustained efficacy and safety of long term on-off treatment with PGL4001 5 or 10mg doses on uterine bleeding, myoma size, pain and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ulipristal acetate (PGL4001) 5mg | Experimental | All subjects will be asked to take a 150mg size tablet (PGL4001 5mg or matching placebo: placebo 5) orally daily for repeated periods 84 days. The first treatment course will start on the first 4 days of menstruation and will be orally administered, once daily (1 tablet of 150mg size), for 84 days. The following three treatment courses should be started in the first two days of a menstrual period. |
|
| Ulipristal acetate (PGL4001) 10mg | Experimental | All subjects will be asked to take a 300mg size tablet (PGL4001 10mg or matching placebo: placebo 10 ) orally daily for repeated periods 84 days. The first treatment course will start on the first 4 days of menstruation and will be orally administered, once daily (1 tablet of 300mg size), for 84 days. The following three treatment courses should be started in the first two days of a menstrual period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PGL4001 5 mg | Drug | PGL4001 5 mg daily administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Who Are in Amenorrhea at the End of All Four Treatment Courses | Amenorrhoea was defined as no more than 1 day of spotting within a 35 day interval. Subjects need to be in amenorrhoea at the end of all four treatment courses, i.e for at least 4x35 days. | 18 months study duration per subject (4 3-month intermittent treatment courses) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Who Were in Amenorrhea at the End of Treatment Course 4 | Amenorrhoea was defined as no more than 1 day of spotting within a 35 day interval. | After 18 months |
| Percentage of Subjects With Controlled Bleeding at the End of All 4 Treatment Courses |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pablo Arrigada, MD | PregLem SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques Universitaires Saint-Luc Gynécologie-Obstétrique | Brussels | 1200 | Belgium | |||
| UZ Leuven Campus Gasthuisberg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26477496 | Derived | Donnez J, Donnez O, Matule D, Ahrendt HJ, Hudecek R, Zatik J, Kasilovskiene Z, Dumitrascu MC, Fernandez H, Barlow DH, Bouchard P, Fauser BC, Bestel E, Loumaye E. Long-term medical management of uterine fibroids with ulipristal acetate. Fertil Steril. 2016 Jan;105(1):165-173.e4. doi: 10.1016/j.fertnstert.2015.09.032. Epub 2015 Oct 23. | |
| 25542821 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ulipristal Acetate (PGL4001) 5mg | PGL4001 5 mg: PGL4001 5 mg daily administration |
| FG001 | Ulipristal Acetate (PGL4001) 10mg | PGL4001 10 mg: PGL4001 10mg daily administration |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| PGL4001 10 mg | Drug | PGL4001 10mg daily administration |
|
|
Controlled bleeding was defined as no episodes of heavy bleeding and a maximum of 8 days of bleeding during the last 56 days of a treatment course. Subjects need to be in controlled bleeding at the end of all 4 treatment courses i.e. for at least 4x56 days. |
| After 18 months |
| Percentage of Change From Baseline to End of Treatment Course 4 in the Total Volume of the 3 Largest Fibroids | For the 3 largest myomas at baseline and the 3 largest myomas at the end of treatment course 4 identified by transvaginal ultrasound, length, height and depth were measured and the volume was estimated by applying the equation for the voulme of an ellipsoid (length x height x depht x π/6). Subjects were exposed to 4 3-month intermittent courses. | After 18 months |
| Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life (Uterine Fibroid Symptom Severity (UFSQoL) | Quality of Life was assessed using a validated questionnaire measuring uterine fibroid symptom severity (UFSQoL) where lower scores indicate fewer symtoms and where a level of 23 has been reported for healthy subject (scale 0-100). Subjects were exposed to 4 3-month intermittent courses. | After 18 months |
| Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life -Uterine Fibroid Health Related Quality of Life (HRQL) | Quality of Life was measured using a validated uterine fibroid symptom questionnaire. Total score for health related quality of Life (HRQL) range from 0 to 100 with higher scores indicating better Quality of Life. Subjects were exposed to 4 3-month intermittent courses. | 18 months |
| Percentage of Change From Baseline to End of Treatment Course 4 in Pain Using a Visual Analogue Scale (VAS) | Pain was assessed using a Visual Analogue Scale (VAS) ranging from 0 to 100 with higher score indicating more severe pain. Subjects were exposed to 4 3-month intermittent courses. | After 18 months |
| Leuven |
| 3000 |
| Belgium |
| CHU de Liège, CHR de la Citadelle Gynécologie-Obstétrique | Liège | 4000 | Belgium |
| CHU Mont-Godinne | Yvoir | 5530 | Belgium |
| Centrum ambulantni gynekologie a primarni pece | Brno | 60200 | Czechia |
| FN Brno Gynekologicko - porodnická klinika | Brno | 62500 | Czechia |
| Sanatorium SANUS | Hradec Králové | 50002 | Czechia |
| Nemocnice Jihlava Gynekologicko - porodnicke oddeleni | Jihlava | 58633 | Czechia |
| G-CENTRUM Olomouc s.r.o. | Olomouc | 77200 | Czechia |
| FN Olomouc, Porodnicko-Gynekologicka klinika | Olomouc | 77220 | Czechia |
| Femina Sana, s.r.o. | Prague | 13000 | Czechia |
| Hôpital Bicêtre - APHP | Le Kremlin-Bicêtre | 94275 | France |
| Hôpital Bichat, Service de Gynécologie Obstétrique | Paris | 75018 | France |
| CHU Bretonneau Service de Gynécologie Obstétrique | Tours | 37044 | France |
| Private practice | Hamburg | 22159 | Germany |
| Private practice | Hamburg | 22359 | Germany |
| Medizinische Hochschule Hannover Klinik für Frauenheilkunde und Geburtshilfe | Hanover | 30625 | Germany |
| Frauenarztpraxis | Hessen | 60322 | Germany |
| Praxis für Frauenheilkunde, Klinische Forschung und Weiterbildung | Magdeburg | 39112 | Germany |
| Technische Universität München | München | 81675 | Germany |
| Rethy Pal Korhaz és Rendelointezet Szuleszeti es Nogyogyaszati Osztaly | Békéscsaba | 5600 | Hungary |
| Institution Robert Karoly Maganklinika | Budapest | 1135 | Hungary |
| Szent Anna Szuleszeti, Nogyogyaszati es Ultrahang Maganrendelo | Debrecen | 4024 | Hungary |
| Josa Andras Oktatokorhaz | Nyíregyháza | 4400 | Hungary |
| Szuleszeti es Nogyogyaszati Osztaly | Szentes | 6600 | Hungary |
| Fejer Megyei Szent Gyorgy Korhaz Szuleszeti es Nogyogyaszati Osztaly | Székesfehérvár | 8000 | Hungary |
| Sandor Dent Bt. | Szolnok | 5000 | Hungary |
| Dipartimento di Ostetricia e Ginecologia, Università degli Studi di Catanzaro "Magna Graecia" | Catanzaro | 88100 | Italy |
| Policlinico Universitario "Agostino Gemelli" | Roma | 00168 | Italy |
| Riga 1. hospital | Riga | 1001 | Latvia |
| Latvian Medical Marine Center | Riga | LV-1005 | Latvia |
| Medical Company "ARS" | Riga | LV-1010 | Latvia |
| Saules Family Medicine Center | Kaunas | 49449 | Lithuania |
| Family Medicine Centre"Seimos Gydytojas" | Vilnius | 01118 | Lithuania |
| Private Clinic "Maxmeda" | Vilnius | 03225 | Lithuania |
| Private Clinic "Kardiolita" | Vilnius | 05263 | Lithuania |
| Centrul Medical SANA SRL | Bucharest | 011025 | Romania |
| Quantum Medical Center SRL Obstetrica-Ginecologie | Bucharest | 011426 | Romania |
| Fortis Medical Center SRL Obstetrica Ginecologie | Bucharest | 012064 | Romania |
| Spitalul Clinic Dr. I.Cantacuzino sectia Obstetrica-Ginecologie | Bucharest | 020475 | Romania |
| Centrul Medical EUROMED SRL, Departamentul de Obtetrica/Ginecologie | Bucharest | 020762 | Romania |
| Spitalul Clinic de Obstetrica | Iași | 700398 | Romania |
| Kharkiv City Perinatal Center Gynaecological Department #1 | Kharkiv | 61176 | Ukraine |
| Municipal Institution "Maternity Hospital #1" City Center of family planning | Odesa | 65039 | Ukraine |
| Maternity Hospital#4 Department of Gynaecology | Zaporizhzhya | 69065 | Ukraine |
| MRC Centre for Reproductive Health University of Edinburgh | Edinburgh | EH16 4TJ | United Kingdom |
| North Middlesex University Hospital NHS Trust | London | N18 1QX | United Kingdom |
| Women's Health, Royal Victoria Infirmary | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| Norfolk & Norwich University Hospital | Norwich | NR47UY | United Kingdom |
| Donnez J, Hudecek R, Donnez O, Matule D, Arhendt HJ, Zatik J, Kasilovskiene Z, Dumitrascu MC, Fernandez H, Barlow DH, Bouchard P, Fauser BC, Bestel E, Terrill P, Osterloh I, Loumaye E. Efficacy and safety of repeated use of ulipristal acetate in uterine fibroids. Fertil Steril. 2015 Feb;103(2):519-27.e3. doi: 10.1016/j.fertnstert.2014.10.038. Epub 2014 Dec 24. |
|
| Safety Population |
|
| Started Treatment Course 2 |
|
| Started Treatment Course 3 |
|
| Started Treatment Course 4 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full Analysis Set 1(all subjects who received study treatment at least once for treatment course 1) (treament group as randomised)
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| ID | Title | Description |
|---|---|---|
| BG000 | Ulipristal Acetate (PGL4001) 5mg | PGL4001 5 mg: PGL4001 5 mg daily administration |
| BG001 | Ulipristal Acetate (PGL4001) 10mg | PGL4001 10 mg: PGL4001 10mg daily administration |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Total volume of the 3 largest myoma | total volume of the three largest myomas (length, height and depth measured using transvaginal ultrasound, volume estimated by applying the equation for the volume of an ellipsoid (length × height × depth × π/6)) | Median | Inter-Quartile Range | cm3 |
| ||||||||||||||||
| Pain Assessment (Visual Analogue Scale) | Pain was assessed using a visual analogue scale (VAS) ranging from 0 to 100 with higher score indicating more severe pain. | Median | Inter-Quartile Range | units on a scale |
| ||||||||||||||||
| Uterine Fibroid Symptom Quality of Life Questionnaire | Quality of Life was assessed using a validated questionnaire measuring uterine fibroid sympotom severity (UFSQoL) where lower scores indicate fewer symptoms and where a level of 23 has been reported for healthy subjects (scale 0-100). Total score for health related QoL (HRQL) ranges from 0 to 100 with higher score indicating better quality of Life. | Median | Inter-Quartile Range | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects Who Are in Amenorrhea at the End of All Four Treatment Courses | Amenorrhoea was defined as no more than 1 day of spotting within a 35 day interval. Subjects need to be in amenorrhoea at the end of all four treatment courses, i.e for at least 4x35 days. | Full Analysis Set 1 (subjects who received study treatment at least once for treatment course 1) (subjects with missing values were excluded from analysis) | Posted | Number | percentage of subjects | 18 months study duration per subject (4 3-month intermittent treatment courses) |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Who Were in Amenorrhea at the End of Treatment Course 4 | Amenorrhoea was defined as no more than 1 day of spotting within a 35 day interval. | Full Analysis Set 1 (all subjects who received study treatment once for treatment course 1) (subjects with missing values were excluded from analysis) | Posted | Number | percentage of participants | After 18 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Controlled Bleeding at the End of All 4 Treatment Courses | Controlled bleeding was defined as no episodes of heavy bleeding and a maximum of 8 days of bleeding during the last 56 days of a treatment course. Subjects need to be in controlled bleeding at the end of all 4 treatment courses i.e. for at least 4x56 days. | Full analysis set 1 (all subject who received study treatment at least once for treatment course 1) (subjects with missing values were excluded from analysis) | Posted | Number | percentage of participants | After 18 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Change From Baseline to End of Treatment Course 4 in the Total Volume of the 3 Largest Fibroids | For the 3 largest myomas at baseline and the 3 largest myomas at the end of treatment course 4 identified by transvaginal ultrasound, length, height and depth were measured and the volume was estimated by applying the equation for the voulme of an ellipsoid (length x height x depht x π/6). Subjects were exposed to 4 3-month intermittent courses. | Full Analysis Set 1 (all subjects who received study treatment at least once for treatment course 1) (subjects with missing values were excluded from analysis) | Posted | Median | Inter-Quartile Range | percentage of change from baseline | After 18 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life (Uterine Fibroid Symptom Severity (UFSQoL) | Quality of Life was assessed using a validated questionnaire measuring uterine fibroid symptom severity (UFSQoL) where lower scores indicate fewer symtoms and where a level of 23 has been reported for healthy subject (scale 0-100). Subjects were exposed to 4 3-month intermittent courses. | Full Analysis Set 1 (all subjects who received study treatment at least once for treatment course 1) (subjects with missing values were excluded from analysis) | Posted | Median | Inter-Quartile Range | percentage of change from baseline | After 18 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life -Uterine Fibroid Health Related Quality of Life (HRQL) | Quality of Life was measured using a validated uterine fibroid symptom questionnaire. Total score for health related quality of Life (HRQL) range from 0 to 100 with higher scores indicating better Quality of Life. Subjects were exposed to 4 3-month intermittent courses. | Full Analysis Set 1 (all subjects who received study treatment at least once for treatment course 1) (subjects with missing values were excluded from analysis) | Posted | Median | Inter-Quartile Range | percentage of change from baseline | 18 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Change From Baseline to End of Treatment Course 4 in Pain Using a Visual Analogue Scale (VAS) | Pain was assessed using a Visual Analogue Scale (VAS) ranging from 0 to 100 with higher score indicating more severe pain. Subjects were exposed to 4 3-month intermittent courses. | FAS1 (all subjects who received study treatment at least once for treatment course 1) (subjects with missing values were excluded from analysis) | Posted | Median | Inter-Quartile Range | percentage of change from baseline | After 18 months |
|
|
Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs.
2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received.
On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ulipristal Acetate (PGL4001) 5mg | PGL4001 5 mg: PGL4001 5 mg daily administration | 16 | 230 | 129 | 230 | ||
| EG001 | Ulipristal Acetate (PGL4001) 10mg | PGL4001 10 mg: PGL4001 10mg daily administration | 12 | 221 | 131 | 221 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Menorrhagia | Reproductive system and breast disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Iron deficiency Anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| arteriospam coronary | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| tinnitus | Ear and labyrinth disorders | MedDRA (15.0) | Systematic Assessment |
| |
| toxic nodular goitre | Endocrine disorders | MedDRA (15.0) | Systematic Assessment |
| |
| abdominal pain | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| small intestinal obstruction | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| accidental death | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| homicide | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| cholelithiasis | Hepatobiliary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| back pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| periarthritis | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
| |
| breast hyperplasia | Reproductive system and breast disorders | MedDRA (15.0) | Systematic Assessment |
| |
| endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
| |
| castleman's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
| |
| carpal tunnel syndrome | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| bipolar disorder | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
| |
| urethral stenesis | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| deep vein thrombosis | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA (15.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| hot flush | Reproductive system and breast disorders | MedDRA (15.0) | Systematic Assessment |
| |
| influenza | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| nasopharyngitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| breast pain/breast tenderness/breast disconfort | Reproductive system and breast disorders | MedDRA (15.0) | Systematic Assessment |
| |
| pelvic pain | Reproductive system and breast disorders | MedDRA (15.0) | Systematic Assessment |
| |
| fatigue | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| nausea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| vaginal discharge | Reproductive system and breast disorders | MedDRA (15.0) | Systematic Assessment |
| |
| back pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| abdominal pain | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| acne | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| anxiety | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
| |
| aneamia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| tonsillitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| hypertension | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
| |
| vertigo | Ear and labyrinth disorders | MedDRA (15.0) | Systematic Assessment |
| |
| weight increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| cystitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| blood creatine phosphokinase increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
PI shall submit to sponsor results communication for review 60 days prior to publication submission. If in the sponsor judgement, publication at a given time would hinder the sponsor's IP development, PI shall consider modifying the publication schedule. PI agrees to delete information identified by sponsor as confidential or defer publication to permit filing of patent application by the sponsor. Publication based on 1 site results shall not be made before the first muti-centre publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Pablo Arriagada | PregLem | 0041228840355 | info@preglem.com |
| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C555622 | ulipristal acetate |
Not provided
Not provided
Not provided
| >=65 years |
|
| Male |
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| Health related Quality of Life (HRQL) |
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